Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial.
Lahiru Russell, Anna Ugalde, Donna Milne, Meinir Krishnasamy, Eric O Seung Chul, David W Austin, Richard Chambers, Liliana Orellana, Patricia M Livingston
Trials April 13, 2018 DOI: 10.1186/s13063-018-2575-x (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial (feasibility study protocol) Peer reviewed |
|---|---|
| Sample size | 75 |
| Population | People with stage 2c or 3 melanoma recruited from a melanoma outpatient clinic |
| Interventions | short daily guided meditation practices automated meditation reminders |
| Dose | 5-10 min daily guided meditation practices |
| Duration | 6-week intervention; questionnaires at baseline and 6-week post-randomisation |
| Topics | Meditation |
| Keywords | Cancer Feasibility Internet-based Melanoma Pilot |
| Key findings | The protocol proposes to assess whether a 6-week online mindfulness-based intervention is feasible for people with stage 2c or 3 melanoma, measured by recruitment, retention, questionnaire completion, usability, acceptability, and adherence, and to explore potential effects on fear of cancer recurrence, worries, rumination, perceived stress, and trait mindfulness to inform a larger clinical trial. |
Abstract
People with a melanoma diagnosis are at risk of recurrence, developing a new primary or experiencing disease progression. Previous studies have suggested that fear of a cancer recurrence is clinically relevant in this group of patients and, if not addressed, can lead to distress. Mindfulness-based interventions have been shown to alleviate symptoms of anxiety and depression among various groups of cancer patients. Online mindfulness-based interventions have the potential to reach people unable to attend face-to-face interventions due to limitations such as cancer-related illness, transportation or time constraints. This study aims to (1) examine whether individuals with a melanoma diagnosis are willing to participate and adhere to a 6-week online mindfulness-based intervention and (2) explore potential benefits of the program on fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness to inform the design of a clinical trial. This is a single-site randomised controlled trial of a feasibility study. Seventy-five participants with stage 2c or 3 melanoma will be recruited from a melanoma outpatient clinic and randomised (2:1) either to an online mindfulness-based program (intervention) or to usual care (control). The intervention is a 6-week program specifically developed for this study. It consists of videos describing the concept of mindfulness, short daily guided meditation practices (5-10 min), automated meditation reminders and instructions for applying mindfulness in daily life to enhance wellbeing. All participants will complete questionnaires at baseline and at 6-week post-randomisation. Participants in the control group will be given access to the online program at the end of the study. Primary outcomes are overall recruitment; retention; extent of questionnaire completion; and usability and acceptability of, and adherence to, the program. The secondary outcomes are fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness measured using validated instruments. This feasibility study will evaluate participants' satisfaction with the program and identify barriers to recruitment and adherence. The recruitment and data collection process will highlight methodological aspects to address in the planning of a larger scale study assessing the impact of an online mindfulness-based intervention on fear of cancer recurrence and wellbeing. Australian New Zealand Clinical Trials Registry, ACTRN12617000081314 . Registered on 16 January 2017.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 13
- Mindfulness: A proposed operational definition. Clinical Psychology Science and Practice 2004
- How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective Perspectives on Psychological Science October 14, 2011
- The meeting of meditative disciplines and western psychology: A mutually enriching dialogue. American Psychologist 2006
- Web-based individual Mindfulness-Based Cognitive Therapy for cancer-related fatigue — A pilot study Internet Interventions April 6, 2015
- Exploring Knowledge, Attitudes, and Practice Associated With Meditation Among Patients With Melanoma. Integrative Cancer Therapies June 2018
and 8 more in the library